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NCT01666678 · ClinicalTrials.gov registry record · Phase 1
Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride Combination
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT01666678: Completed Phase 1 study, sponsored by Bayer.
NCT01666678 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01666678, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The purpose of the current trial is to evaluate the bioavailability of a single oral dose of naproxen sodium 440 mg and DPH HCL 50 mg under fasting and fed conditions and currently marketed single ingredient products containing naproxen sodium (2 x Aleve® 220 mg tablets) or DPH HCL (2 Allergy Relief x 25 mg tablets) under fasting conditions.
Interventions
- DRUG BAY98-7111
- DRUG Naproxen Sodium (Aleve, BAYH6689)
- DRUG Diphenhydramine HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2012-01 |
| Est. Completion | 2012-03 |
| Phase | Phase 1 |
What the finished NCT01666678 record still lists
NCT01666678 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 3 interventions - of which BAY98-7111 is the first listed.
NCT01666678 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01666678 about?
NCT01666678 is a clinical study titled "Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride Combination". The purpose of the current trial is to evaluate the bioavailability of a single oral dose of naproxen sodium 440 mg and DPH HCL 50 mg under fasting and fed conditions and currently marketed single ingredient products containing naproxen sodium (2 x Aleve® 220 mg tablets) or DPH HCL (2 Allergy Relief...
What is the current status of trial NCT01666678?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2012-01. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01666678?
The interventions under investigation include: BAY98-7111 (DRUG), Naproxen Sodium (Aleve, BAYH6689) (DRUG), Diphenhydramine HCl (DRUG).
Who is sponsoring clinical trial NCT01666678?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01666678's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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